NCT03503773CompletedPhase 2
A Phase 2, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System Kit, in Subjects With Hypertension, in the Absence of Antihypertensive Medications
Ablative Solutions, Inc.4 sites in 4 countries350 target enrollmentStarted: September 24, 2018Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Ablative Solutions, Inc.
- Enrollment
- 350
- Locations
- 4
- Primary Endpoint
- Changes in Systolic Ambulatory Blood Pressure
Study Overview
Brief Summary
To obtain an assessment of the efficacy and safety of renal denervation by alcohol-mediated neurolysis using the Peregrine Kit in hypertensive subjects in the absence of antihypertensive medications.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Blinded (The subject, sponsor, and hypertensionist/nephrologist performing the screening and follow-up assessments are blinded. The interventionalist and cath lab staff are unblinded.)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has 3 office blood pressure measurements with a mean office systolic blood pressure (SBP) of ≥140 mmHg and ≤180 mmHg, AND a mean office diastolic blood pressure (DBP) of ≥90 mmHg.
- •Subject is willing to discontinue any current antihypertensive medications during the run-in period and the post-treatment period.
- •Has a mean 24-hour ambulatory SBP of ≥135 mmHg and ≤170 mmHg with ≥70% valid readings
Exclusion Criteria
- •Subject has renal artery anatomy abnormalities.
- •Subject has an estimated glomerular filtration rate (eGFR) of ≤45 mL/min/1.73 m2, based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation; or is on chronic renal replacement therapy.
- •Subject has documented sleep apnea.
- •Subject has any of the following conditions: severe cardiac valve stenosis, heart failure (New York Heart Association [NYHA] Class III or IV), chronic atrial fibrillation, and known primary pulmonary hypertension (>60 mmHg pulmonary artery or right ventricular systolic pressure).
- •Subject is pregnant or lactating at the time of enrollment or planning to become pregnant during the trial time period (female subjects only).
- •Subject is being treated chronically (e.g. daily use) with NSAIDs, immunosuppressive medications, or immunosuppressive doses of steroids. Aspirin therapy and nasal pulmonary inhalants are allowed.
- •Subject has a history of myocardial infarction, unstable angina pectoris, or stroke/TIA within 6 months prior to the planned procedure.
Arms & Interventions
Treatment Arm:
Experimental
Renal denervation (using the Peregrine Kit) performed with alcohol infused through the Peregrine Catheter
Intervention: Alcohol (Drug)
Sham Control Arm
Sham Comparator
Only renal angiography performed
Intervention: Sham control (Other)
Outcomes
Primary Outcomes
Changes in Systolic Ambulatory Blood Pressure
Time Frame: Baseline to 8 weeks post-treatment
Change from baseline in mean 24-hour ambulatory systolic blood pressure
Secondary Outcomes
- Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 6 Months(6 months)
- Change in Mean 24-Hour Ambulatory Systolic Blood Pressure at 12 Months(12 months)
- Change in Office SBP at 8 Weeks(8 weeks)
- Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 8 Weeks(8 weeks)
- Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 6 Months(6 months)
- Change in Mean 24-Hour Ambulatory Diastolic Blood Pressure at 12 Months(12 months)
- Number of Participants With Major Adverse Events (MAEs)(30 days post procedure)
- Use of Antihypertensive Medication(s)(8 weeks)
- Change in Mean Daytime Ambulatory Systolic Blood Pressure at 8 Weeks(8 weeks)
- Change in Mean Daytime Ambulatory Systolic Blood Pressure at 6 Months(6 months)
- Change in Mean Daytime Ambulatory Systolic Blood Pressure at 12 Months(12 months)
- Mean Daytime Ambulatory Diastolic Blood Pressure(8 weeks)
- Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 6 Months(6 months)
- Change in Mean Daytime Ambulatory Diastolic Blood Pressure at 12 Months(12 months)
- Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 8 Weeks(8 weeks)
- Change in Mean Nighttime Ambulatory Systolic Blood Pressure at 6 Months(6 months)
- Change in Mean Nighttime Ambulatory Systolic Blood Pressure to 12 Months(12 months)
- Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 8 Weeks(8 weeks)
- Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 6 Months(6 months)
- Change in Mean Nighttime Ambulatory Diastolic Blood Pressure at 12 Months(12 months)
- Change in Mean Office SBP at 6 Months(6 months)
- Change in Mean Office SBP to 12 Months(12 months)
- Change in Mean Office DBP to 8 Weeks(8 weeks)
- Change in Mean Office DBP to 6 Months(6 months)
- Change in Mean Office DBP at 12 Months(12 months)
Investigators
Study Sites (4)
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